Summary of Position

Perform and be responsible for Quality Assurance activities in order to comply with applicable SOP's and cGMPs. Will coordinate and oversee the work of others. Work under limited supervision with considerable latitude for the use of initiative and independent judgment. Ability to manage projects using cross-functional teams.

Work schedule:

Sunday - Wednesday 4:00 AM - 2:30 PM

Essential Functions

• Ensure completion of required training, work (including document review, batch release, QA on-the-floor, AQLs), and timely release of materials and batches.
• Responsible for the thorough and efficient review and disposition of completed batch record documentation ensuring adherence to Good Documentation Practices/cGMPs and applicable local procedures.
• Responsible for performing and/ or overseeing performance of Quality Assurance on the floor tasks including but not limited to performing AQL inspections, performing clearances for manufacturing areas and providing Quality input and guidance to manufacturing personnel.
• Responsible for dispositioning finished product, raw materials/ components and intermediates through an all-inclusive documentation review and cross reference of electronic quality systems.
• Responsible with release of incoming raw materials and components per applicable local procedures. This may include support for labeling dispositioned raw materials and components with appropriate status indicator labels.
• Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOP’s.
• Ensure the maintenance of department, premises and equipment.
• Ensure that all assigned training is carried out to competently perform assigned tasks confidently and consistently.
• Perform all work in compliance with site safety and radiation protection guidelines.
• Collaborate with other team members to ensure assigned tasks are performed in a timely manner.
• Must demonstrate flexibility in adjusting to changing priorities and schedules.
• Attend mandatory trainings as required by site regulatory requirements and management.
• Perform other general duties associated with the position as required by supervision.

Requirements

• Bachelor’s degree preferred in life science or a related field; or equivalent experience.
• 6 years or more of relevant general quality/quality control/production experience in a cGMP facility required.
• Excellent attention to detail skillset.
• Experience with computer data entry required. Proficient in use of Microsoft suite office products.
• Strong communication, organization and time management skills are necessary.
• Ability to communicate professionally, knowledgeably and efficiently.
• Strong problem solving, decision making, verbal and written communications skills are necessary.
• Leadership skills including but not limited to mentoring, assignments of work flows, personnel development, personnel performance management.
• Must be able to analyze causes of interpersonal conflict and resolve complex communication issues (i.e., undefined roles, objectives and information gaps).
• Must be able to resolve problems, handle conflict and make effective decisions under pressure. Excellent writing and verbal communications skills.
• Ability to give, receive, and analyze information, formulate work plans, prepare written materials and articulate goals and action plans.
• Action oriented/drives for results. Ability to multitask projects that support personal and site goals.
• Ability to communicate professionally, knowledgeably and efficiently.
• Excellent writing and verbal communications skills.
• Ability to do simple to complex math calculations, input data into the computer and analyze data as required.
• Ability to work independently and as part of a team.
• Ability to plan, prioritize and delegate daily QA Release job tasks.
• Ability to identify and drive implementation of initiatives to meet or exceed departmental metrics and goals.
  

Working Conditions:

• Willingness to work in a team-based environment. Close attention to detail required. May be required to sit or stand for long periods of time while performing duties. Must be able to work outside of regular work hours, including weekends and overtime as needed.
• Willingness to support Manufacturing operations as Quality on-the-floor. This may require specialized gowning and associated qualifications required for the area.
• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Must be able to work outside of regular work hours.
• Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
• Must possess good hand-eye coordination.